Gordon Medical Community Sponsored Metabolomic Study (Individual Data)

[Neunistiva]

The replication work have already been funded.

A list of upcoming metabolic and metabolomic studies

If I am not mistaken, us paying our own tests would allow people from all over the world to get tested which would be much more robust, as opposed to limiting the number of patients and the geographic location.

 

[Kati]

If I am not mistaken, us paying our own tests would allow people from all over the world to get tested which would be much more robust, as opposed to limiting the number of patients and the geographic location.

However people sending their blood increase the risk of having a mixt cohort.

 

[Sidereal]

I just want to preface my critique by saying that I am very enthusiastic about the PNAS study and think it's a breakthrough. I think Naviaux's Q&A has been superb and the most insightful thing I've ever read about this illness (mostly I say that because I've been saying the same things for years so the confirmation bias is rather self-serving and pleasing to my ego ). I don't like the relentless negativity I've seen some people spreading about this study so my critiques are posted here not to upset Gordon or anyone else but in a constructive fashion. I very much want them to continue studying this disease and I wish them all the best.

This study, as currently proposed, could only be an exploratory fishing expedition at best to help them figure out if the initially identified metabolites in the small sample of Gordon's patients are cropping up in people from all over the world who are diagnosed with CFS - whatever that is - using presumably different criteria and diagnosed by clinicians with vastly varied levels of skill and experience at diagnosing CFS. But, as currently presented, I would agree with Edwards that it would be virtually unpublishable. The sampling bias alone is a big problem. People who can afford to spend 1500 bucks on an experimental test are not representative of the wider population of people with this diagnosis. Sending their own data in, that's self-selection bias, another big problem introduced right there. Also, how is a clinical diagnosis of CFS going to be confirmed in people halfway across the world, are they just going to take patients' word for it? What if they were diagnosed with CFS like I was after virtually no other conditions had been excluded and minimal workup, until someone later discovered I had two 'fatiguing' autoimmune diseases. And so on.

 

[BurnA]

I would agree with Edwards that it would be virtually unpublishable. The sampling bias alone is a big problem. People who can afford to spend 1500 bucks on an experimental test are not representative of the wider population of people with this diagnosis.

Agreed it might be unpublishable but would scientists not do work all the time that is unpublishable - it doesn't mean they aren't learning from it or that it might shape future publishable tests. I don't know, I just imagine that to be the case but would be good to hear from experience researchers on this topic.

On the representative bias I think the money factor would be less of an issue than you think ( I am going by my interpretation of @Jonathan Edwards experience )

Either way everyone has the right to make up their own mind.

 

[Sidereal]

Agreed it might be unpublishable but would scientists not do work all the time that is unpublishable - it doesn't mean they aren't learning from it or that it might shape future publishable tests.

Yes, I didn't say it was useless. In their situation I'd be wanting to have as many patient blood samples as I could get my hands on to look at what's going on and inform future studies where patients are properly recruited.

 

[trishrhymes]

I just want to preface my critique by saying that I am very enthusiastic about the PNAS study and think it's a breakthrough. I think Naviaux's Q&A has been superb and the most insightful thing I've ever read about this illness (mostly I say that because I've been saying the same things for years so the confirmation bias is rather self-serving and pleasing to my ego ). I don't like the relentless negativity I've seen some people spreading about this study so my critiques are posted here not to upset Gordon or anyone else but in a constructive fashion. I very much want them to continue studying this disease and I wish them all the best.

This study, as currently proposed, could only be an exploratory fishing expedition at best to help them figure out if the initially identified metabolites in the small sample of Gordon's patients are cropping up in people from all over the world who are diagnosed with CFS - whatever that is - using presumably different criteria and diagnosed by clinicians with vastly varied levels of skill and experience at diagnosing CFS. But, as currently presented, I would agree with Edwards that it would be virtually unpublishable. The sampling bias alone is a big problem. People who can afford to spend 1500 bucks on an experimental test are not representative of the wider population of people with this diagnosis. Sending their own data in, that's self-selection bias, another big problem introduced right there. Also, how is a clinical diagnosis of CFS going to be confirmed in people halfway across the world, are they just going to take patients' word for it? What if they were diagnosed with CFS like I was after virtually no other conditions had been excluded and minimal workup, until someone later discovered I had two 'fatiguing' autoimmune diseases. And so on.

I've just come across this thread and caught up with the comments.

It does seem a pity to me that some people are quick to dive in with criticisms of individuals based on limited information, rather than framing them as polite questions. Particularly as we know that some doctors who are 'on our side' such as Myhill and Speight have been censured by authorities unjustly.

I am excited by the Naviaux study. I see it as a bit like an exploratory aerial geological survey of a huge country to look for areas that might contain valuable minerals. The next step, to continue the metaphor, is to look more closely on the ground and then sink test mines to see whether the minerals are there in economically viable quantities.

Expecting to be able to move straight on to building the mine after the aerial survey is premature, but that does not mean it was unscientific or invalid. It provides valuable information on which more detailed hypotheses can be developed, and testing of these can be done.

To return to metabolomics, I'm delighted that bigger studies are being done to seek wider confirmation, and different people are doing them also. It may be a long process, and I am trying to be patient and wait for these before I get too excited.

As to individuals paying to get their own data, I don't see a problem with this for those who can afford it. To go back to my metaphor, their data could be added to the pool of data at the 'aerial survey' level, ie provide valuable added clues of where to look and what to look for. I don't see that such a self selecting sample could be included in a randomise controlled trial, but it can contribute valuable information towards the development of hypotheses to be tested in such trials. And as some people have said, it may provide useful data in future for those individual patients if treatments can be developed.

It may turn out that the few dozen patients in the Naviaux study are not completely representative of all ME/CFS patients, and the larger studies will help to find this out. It may turn out that the diagnostic tests being developed need to be modified as a result, but the work on developing the technology will not be wasted. I'm pleased that work is already under way to develop the technology to make a diagnostic test possible.

Perhaps the fact that Dr Davis and Dr Naviaux have been so willing to discuss the issues with us has inflated people's expectations. It is early days. Exciting early days, but we can't expect them to magically provide all the answers yet.

As to the stuff about Dr Gordon, I understand that his involvement is in providing patients from his clinic for the Naviaux study, just as all medical studies need to use doctors to find patients for them. I don't see the fact that his clinic sells vitamins and homeopathic remedies as having any relevance at all to the quality of the science done by Dr Naviaux.

Edit: While I was writing this, 2 others have made the same point much more succinctly! What a great community!

 

[BruceInOz]

If I am not mistaken, us paying our own tests would allow people from all over the world to get tested which would be much more robust, as opposed to limiting the number of patients and the geographic location.

But it would introduce a specific bias that may or may not be important - the samples would all come from those that can afford the test.

Oops! posted this before reading Sidereal who said the same thing!

 

[Sidereal]

It provides valuable information on which more detailed hypotheses can be developed, and testing of these can be done.

This. As Davis pointed out previously, the NIH won't fund anything because there are no hypotheses. Why are there no hypotheses? Because virtually zero useful data has been collected thus far so no one has any clue what to hypothesise. I think low-quality studies like this are very useful because they can inform future hypothesis-driven research which would not be possible unless you collect some preliminary data first and get ideas about what to look into.

As to the point made previously that pathophysiology of other diseases was not discovered in this fashion, well, ME/CFS is clearly not like other diseases or we wouldn't be where we are. ME/CFS is nothing like hyperparathyroidism which involves dysfunction of just one organ so yeah once you zoom in on the right organ/tissue you can get 2-3 relevant metabolites and that's that. ME/CFS involves dysfunctional metabolic processes in every cell of the body. Standard research methods have been tried for decades and they have failed because they are fundamentally wrong for approaching a disease like this. This is why we have nothing to show for, because studies have always tried to measure one or two things since the technology wasn't available to measure 500 things at once. It's time to abandon our dependency on antiquated research methods taught to medics and move on with big data and metabolomics which may well be where the future of medical research lies for diseases involving really complex multisystemic mechanisms like ME/CFS or neuropsychiatric conditions like autism, depression, PTSD etc. which is what Naviaux seems to be doing. It's probably going to take the medical profession decades to move on with the times judging by their attitudes and past behaviour towards people with complex diseases.

 

[hixxy]

But it would introduce a specific bias that may or may not be important - the samples would all come from those that can afford the test.

Oops! posted this before reading Sidereal who said the same thing!

The clinics that the patients in these studies are being drawn from aren't exactly known for being cheap, so there's already a socio-economic bias.

 

[Sasha]

I think we need to be aware that there will be biases and I hope that the researchers will collect data at the time of sample collection that will at least allow them to describe the characteristics of the sample and create subsamples (e.g. those with an ME/CFS diagnosis confirmed by a specialist).

 

[Tuha]

Your input is much appreciated and it's nice to hear that you have the utmost confidence with Dr. Gordon. It is exemptions like to hear that he even made house calls to treat Whitney. It is so rare to see such dedication from doctors.

This forum is a place where patients can feel free to talk about their concerns and feel safe to do so. It is important for us to discuss concerns and yes at times it might mean that we criticize the government and even doctors.

It is not okay to spread lies and when that happens either by mistake or on purpose others will come on and point it out and the facts come out - as they should.

When I was stating that $1,500 is steep for patients - that's exactly what I meant. I didn't say that dr. Gordon is taking a profit.

ME patients - especially those that have been ill a very long time, are very constrained financially. We have lost our incomes and the cost of medical care for us is a huge strain. It is not unusual for patients to spend tens of thousands of dollars if not more on their basic medical care - just to survive.

So - although I understand that ME researchers are stuck because they do not get federal funding for thei studies, patients in the majority are tapped out. We have given to our researchers time and time again. There comes a point when it is too much pressure on patients who are so sick that they barely live a life.

So, when they are told to extend more and more, I think it's understandable that they would question exactly where it is going and why.

I think it is the patients' rights to question whether this might be premature. Is there enough evidence yet, that this test will make a real difference in our lives. For many of us this $1,500 might mean that we eat less or do without medications for a while.

For those for whom money is no object, great - they don't need to be so inquiring but I don't think that's the case for most of us.

To me personally, the fact that Dr. Gordon's practice does not accept any medical insurance is disturbing as well. Some alternative practitioners do not accept insurance because they are not medical doctors but, Dr. Gordon is - so I'm not sure why he doesn't take insurance.

There are other doctors whose practice is similar and patients have had many complaints. The driving force being making as much money as possible from desperate patients.

We have been burned by "well meaning" doctors selling tests prematurely which turned out to be fake. I'm not saying this is the case here. I'm just explaining why we are careful.

To state that we should not discuss doctors because they mean well and do research for us, I don't think is fair. I think that we should be able to state facts, discuss them and everyone is free to come to their own conclusion.

I dont understand this problem. None force the patients to do the tests. Everyone knows that the results have to be replicated and we are just on the beginning. There is just an offer that if you want you can take that risk and do it even if it´s premature.

And yes many patients cannot pay it. It´s sad but sorry this world works like this. But if we will move the science also the patients who are poor will profit from it.

I would blame NIH that they dont give any sources for ME research and not our researchers that they try to find money. i dont find this way unethical.

Also I saw some really nesty disgusting comments adressed to these researchers. It´s again from the group of retrovirus theory fans. The criticism can be here but in constructive way. They simply critic the researchers because of their scientific opinion and they look everywhere for a conspiracy. We have here 1 important thing - several researchers (Naviaux/Davis, Hanson, Australian group) found metabolic problems (hypometabolic state) in ME patients. Of course we need replication and bigger studies but it looks promising. Then the researchers proposed some hypothesis why it´s like this. And now the retrovirus fans jump here again with their disgusting comments. But the researchers are not against them - they have simply different opinion. if they believe so in retroviruses - they can create a campaign for Mikovits or other researchers who would like to check retrovirus hypothesis and thry to find money for their research. Personally I dont believe in retrovirus theory but I dont arrive to those groups and I dont put there disgusting comments and dont attack them because I think that their theory is wrong.

 

[Tuha]

ok, with trepidation...

I'm pretty sure that we all hope that the Navaiaux paper is a huge break-through and that, when the history of the discovery of the cause of CFS is written, Eric Gordon and the others working on metabolomic research at this early stage are recognised as heroes.

So, if we are identifying the issues in this thread, you can be sure that some who are part of the industry built around a psychogenic model of CFS and other illnesses will too.

I can also imagine rocking up to even an open-minded GP excitedly clutching the Naviaux paper saying 'this is the breakthrough!', only to have him come back saying 'well four of the authors are from a clinic that sells homeopathic remedies and the clinic owner has been prescribing inappropriately and the clinic is selling an expensive test promoted by the research' and then not bothering to read anything else I might bring.

And I can imagine friends or family who really don't know what to make of this illness googling and coming up with these issues.

Isn't it far better that, rather than being blindsided by those accusations, we may choose to not wave the research in front of our sceptical doctors and family just yet. And/or perhaps feel able to respond, because we have had people contribute information, with something like

'well, many of Eric Gordon's patients say he and his clinic staff really care for patients and the accusation relating to the prescribing is just a result of him wanting to help alleviate his patient's pain. And the supplements sold aren't overpriced and it's a service to patients as the supplements can be hard to get hold of. And the actual cost of the testing is expensive and offering the test is a legitimate way to get funding for more research given the lack of government funding'.

And, anyway, the analysis was done by experienced researchers, not the clinic, and a number of other research groups are in the process of doing similar studies'.​

Transparency allows truth to shine through. Obviously we shouldn't be nasty about things but I think airing concerns is an important function of the forum.

I think we will not avoid the scepticism of some sceptical doctor yet. We are not that far yet but I think it´s not important now - we waited so many years that we can wait some more. What is the most important now to continue this high quality research and to hope that the results will be validated. Only scientific proves can persuade the sceptical doctors.

Personally I think that the patients community should more focus on funding our researchers. We should be able to fund at least Davis and Lipkin and maybe some more smaller group (IiME,...). We try to speculate too much in his time.

 

[Sidereal]

In the real world outside of planned economies like the former communist block or North Korea, things "cost what they cost" i.e. what the market is willing to pay. If there are people out there willing to shell out 1500 bucks for this test, which I personally wouldn't do in a million years until more replications have been published, then that is what the test costs. Things don't really have any inherent value X and it is not immoral to sell things at a profit. They have to keep the lights on in their labs.

I don't understand the argument that somehow it is immoral to sell this expensive test because not every last ME/CFS patient on disability can afford it. Who said you should be able to purchase whatever you think you are entitled to? When has the world ever worked that way? Would you go into a supermarket or to the doctor or the pharmacy and complain that things are too expensive for disabled patients to afford? Would you go into an Apple store and complain that the disabled can't afford an iPhone 7? Should your landlord set the rent for your apartment at 1 dollar per month because it would be unfair to expect disabled people to fork out tons of their disability money on rent? No. Well, this situation is no different. No one is forcing you to purchase this test. If you don't think the test is worth your money then wait for your NHS or Medicare or whatever to pay for it if and when it becomes validated and part of the normal medical system.

 

[BurnA]

Also I saw some really nesty disgusting comments adressed to these researchers. It´s again from the group of retrovirus theory fans.

I saw Janet defending the researchers on Twitter.
I think this is a new low.

@Rose49 please don't feel dispirited in any way, you have no idea how much the work you Ron and Linda do, is appreciated all around the world.

 

[Undisclosed]

Mass Spectrometers used for metabolomics testing cost a million dollars each.
He's sending the samples to Dr. Naviaux for the test. The $1500 he's asking for: $1000 goes to Naviaux (it's expensive to do this test!) and $500 goes to the computer process of getting out the individual's data, and all the blood processing, etc. He made it a donation so it could be tax deductible. Perhaps you'd rather have him just charge the fee. An MRI costs much more than this, but is covered by insurance. There is no insurance for CFS patients for this stuff, because of the extreme neglect of the whole medical profession, CDC, NIH, etc. It is really hard to get funding for this disease, so researchers are getting creative and using crowd funding-type methods.

Thank you for clarifying that @Rose49

Dr. Gordon has been available by phone for us, and has driven all the way down here to see Whitney several times. I think it is really sad to see people talking like this about him. We need docs like him. He is trying to help us. He's another person who is totally dedicated to helping people with CFS. He is feeling REALLY bad about what is being said about him on here and on twitter. I understand that people are wary and skeptical, given the history of this disease. Now we have some really good people trying to help. Maybe we should be grateful and not do things that drive them away. I think there is a way to ask questions that does not accuse people or assume they are bad and unethical.

It is sad to see people digging up irrelevant stuff about one of the authors of the study. Unfortunately, this happens all the time all of the internet. It's hard to read stuff written about you on the internet that isn't true or comes from pure speculation. Please tell Dr Gordon to try to focus on the positive stuff and not get too upset by the negative comments. For every negative comment out there, there always seems to be many many more positive ones as evidenced in this thread. As a population of people that have been on the receiving end of lots of negative events, most are just wary now.

Wow! This is sounding more and more like XMRV 2.0!
We get the big break though paper and before anyone can confirm it, the affiliated lab offers an expensive lab test. What did Yogi Berra say? "It's deja vu, all over again!"

One word for that comment -- Ridiculous.
Have you even read the Naviaux study:

Chronic fatigue syndrome is a multisystem disease that causes long-term pain and disability. It is difficult to diagnose because of its protean symptoms and the lack of a diagnostic laboratory test. We report that targeted, broad-spectrum metabolomics of plasma not only revealed a characteristic chemical signature but also revealed an unexpected underlying biology. Metabolomics showed that chronic fatigue syndrome is a highly concerted hypometabolic response to environmental stress that traces to mitochondria and was similar to the classically studied developmental state of dauer. This discovery opens a fresh path for the rational development of new therapeutics and identifies metabolomics as a powerful tool to identify the chemical differences that contribute to health and disease.

There is absolutely no similarity whatsoever.

Transparency allows truth to shine through. Obviously we shouldn't be nasty about things but I think airing concerns is an important function of the forum.

Totally agree with this. To know the truth, one has to ask what the truth is if it isn't readily apparent. @Rose49 has been filling in some details for us which has been very helpful. I just hate to see somebody torn down via destructive criticism rather than constructive criticism. I wonder, despite some of the comments on this thread, if we could ask Dr Gordon some questions that would provide some further clarity to any questions in a constructive manner.

I saw Janet defending the researchers on Twitter.
I think this is a new low.

@Rose49 please don't feel dispirited in any way, you have no idea how much the work you Ron and Linda do, is appreciated all around the world.

It is disheartening and yes don't let these people get you down because they are in a distinct minority.

 

[JamBob]

I'm surprised everyone is complaining about the cost of this test. It's not like anyone is forced to opt in to it.

For the same cost(1500 US dollars) you could get information about only 6-7 different parameters at the main private lab used for private testing in the UK. In contrast this test gives you information about 600 parameters, so it seems like a good deal to me.

It's true this test isn't validated as a diagnostic test but I never thought of it in that way. It would be more useful as an exploratory test. Metabolomics may not currently be used in clinical practice but it's not like it's some quack test - there are metabolomics labs in all the big research universities.

Also, just because something isn't "validated" doesn't mean it isn't useful. For example, lots of doctors in the UK poo-poo the 23 and Me tests, but my relative did this and found they have a very serious genetic disease which doctors in the UK never bother to test for and patients often only get diagnosed when they start to have very serious life threatening complications. As my relative has now caught the disease early (thanks to 23 and me) they can get treatment before the complications happen.

So I think patients should go into this fully informed about why they are doing this test (ie. doctors aren't going to be interested and it may only be useful for one's own information) but I don't see why patients shouldn't have the option.

I plan to save up for the Laurel Crosby test - I am interested to see the results as I know I am metabolically deranged!

 

[Binkie4]

Hi everyone
First post ever.
If one wished to consider paying the 1500$ for metabolomics testing + giving a blood donation from an ME patient+ bringing along a relative without ME who is willing to be tested, how would one go about it? Not decided yet but thinking about it. Is there a link that would provide some practical details?
I live in UK but will be visiting New York in about 2/3 weeks. Was diagnosed with ME in 2008. Are there specific doctors who would take the samples and then send them in the correct way to the labs. Which labs are offering this? Does the 1500$ include all the costs?
Not yet decided but would like to think too about the practicalities of doing it.

 

[RL_sparky]

If your interested in doing the testing being done through Gordon Medical then here is the number to answer your questions:
Address: 3471 Regional Pkwy, Santa Rosa, CA 95403
Phone: (707) 575-5180
If your willing to wait Ron Davis and his team are working on a cheaper test that you can do in the UK which should be available fairly soon. @Ben Howell can fill you in on the details when it becomes available.

 

[Binkie4]

Thank you RL_sparky. Have a good feel about Ron Davis, and if he is testing in UK may wait for that. Exciting times!

 

[Research 1st]

Does anyone know if Gordon Medicals Metabolomic blood test is the same as the Dr Navieux/DrDavis assay in terms of analytes measured, e.g. Sphingomyelin? or is it only similar?

Even then, is it using the same assay as the one from Metabolon?

For example this doctor & scientist appears to have had a Metabolomics test , from Metabolon, for her CFS/GI/Fatigue illness last year and mentions someone called Whitney.

You can see here giving an extensive talk about a test (she doesn't name it) at the 'Personalized Medicine World Conference (PMWC) 2016', here:

If we aren't allowed to discuss the differences between tests publicly, could someone kindly PM me?

Thank you.